The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,028
Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
Short Term Primary End Point
Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Time frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
Long Term Primary End Point
Survival at 2 years free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Time frame: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Powered Secondary End Point: Pump Replacement at Two Years
In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.
Time frame: As they occur up to 24 months or to Outcome, whichever occurs first
EuroQoL 5D-5L (EQ-5D-5L) Total Score
Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Time frame: Baseline to 24 months
EuroQol-5D-5L Visual Analogue Scale
Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
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Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, United States
Cedars Sinai Medical Center
Beverly Hills, California, United States
University of California, San Diego
La Jolla, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
...and 59 more locations
Time frame: Baseline to 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline to 24 months
Six Minute Walk Test
Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
Time frame: Baseline to 24 months
New York Heart Association (NYHA) Classification
Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.
Time frame: Baseline to 24 months
Rehospitalizations
Rate of all cause rehospitalization
Time frame: From initial discharge to two years post-implant
Adverse Event Rates
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time frame: Two years post-implant